Cleared Traditional

SEMINAL FLUID COLLECTION KIT II (K954791) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954791 · Apex Medical Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
79d
Days
Class 2
Risk

K954791 is an FDA 510(k) clearance for the SEMINAL FLUID COLLECTION KIT II. Classified as Condom (product code HIS), Class II - Special Controls.

Submitted by Apex Medical Technologies, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1996 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5300 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Apex Medical Technologies, Inc. devices

Submission Details

510(k) Number K954791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1995
Decision Date January 05, 1996
Days to Decision 79 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 160d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HIS Condom
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HIS Condom

All 400
Devices cleared under the same product code (HIS) and FDA review panel - the closest regulatory comparables to K954791.
Male Latex Condom HA
K252622 · Okamoto USA, Inc. · May 2026
LifeStyles® HydraFeel Natural Rubber Latex Condom
K252521 · Suretex Limited · Nov 2025
Natural rubber latex male condom
K250034 · Shaoguan Regenex Pharmaceuticals Co., Ltd. · Jul 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · Lelo, Inc. · Mar 2025
Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy)
K243640 · Church & Dwight Co., Inc. · Feb 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · Okamoto USA, Inc. · Feb 2025